PatientsVille.com

Cough research study

What is the primary objective of this study?

The investigators want to see whether the test drug in this research study,
2-hydroxypropyl-beta-cyclodextrin (2HPBCD), might potentially be able to improve cough in
healthy volunteers. The investigators are initially recruiting healthy volunteers such as who
are free from any respiratory disease and not on any concurrent medication, so there are no
confusing effects from pre-existing respiratory symptoms or disease, nor interaction of any
medication with the test drug.

Who is eligible to participate?

Inclusion Criteria:
- Healthy non−smoking participants (we have excluded smoking participants in light of
the greater potential for cough to be present as a result of their smoking habit and
they may be unduly sensitive to inhaled cough stimuli, such as the inhaled capsaicin
cough challenge)
- Age 18−65 years
- No history of respiratory disease
- Normal baseline spirometry as predicted for age, sex and height (we have excluded
those with abnormal spirometry, as we aim to induce cough in our otherwise healthy
volunteer participants. Also, abnormal spirometry in the presence of no respiratory
symptoms − may indicate an underlying lung condition that needs attention, and such
participants will be told their result and with their consent, the information will be
forwarded to their General Practitioner, as part of the safety and well−being of the
research participant).
- No history of allergic disease i.e., a negative skin prick test(we have excluded those
with allergic disease as they may have a heightened sensitivity to inhaled cough
stimuli, such as the inhaled capsaicin cough challenge)
- Participants who are free from significant cardiac, gastrointestinal, hepatic, renal,
haematological, neurological and psychiatric disease
- Not taking any regular medication, other than the oral contraceptive pill (we do not
want any interaction with other medication that the participant may be taking i.e. we
hope to measure the cough 'tussive' response in our healthy volunteers solely as a
result of the effect of our compound under investigation, 2HPBCD)
- All participants must have a minimum gap of one−month from completion of a previous
study, before commencement in this current study
Exclusion Criteria:
- History of respiratory disease (we have excluded those with respiratory disease so
that the outcome, attenuation of the induced capsaicin cough response by intravenous
2HPBCD, is unaffected by any respiratory disease status of the participant)
- History of upper respiratory tract infection or respiratory symptoms in the preceding
six weeks (as respiratory tract infections may cause cough or highly sensitize the
respiratory airways to inhaled cough stimuli, such as the inhaled capsaicin cough
challenge i.e. the induced cough capsaicin challenge will not be a true reflection of
cough in the healthy volunteer participant)
- Evidence of a positive pregnancy test (urine beta−human chorionic gonadotrophin level)
for female volunteers or female participants that are pregnant or lactating or are
likely to become pregnant during the trial. Women of childbearing potential may be
included in the study if, in the opinion of the investigator, they are taking adequate
contraceptive precautions
- Gastrointestinal symptoms such as a recent alteration in bowel habit or new bowel
symtpoms including participants with a known or suspected history of lactose
intolerance (as 2HPBCD when given as an oral tablet in chronic dosing, has been shown
to sometimes cause flatulence, diarrhea, soft stools and abdominal cramps)
- Participants susceptible to renal impairment from their medical history (symptoms of
renal failure, medical conditions predisposing to renal impairment such as diabetes,
history of recurrent urinary infection either as an adult or in childhood, history of
peripheral vascular disease/stroke/coronary heart
disease/hypercholestrolaemia/hyperlipidaemia), or from their medical examination
(kidney size, renal bruits, peripheral upper and lower limb arterial pulses)or from
their urine analysis on urine 'dipstick' (glucose, protein, blood). Any positive
finding listed above will lead to exclusion of the participant from the clinical study
- Participants with an abnormal urine cytology. Any positive finding in this tests will
lead to exclusion of the participant from the clinical study
- Participants who are unable to give informed consent

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:cyclodextrinintravenous

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

2

Study Status

Terminated

Start Date: August 2016

Completed Date: December 2017

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Capsaicin Cough Challenge

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: O S Usmani, MD, PhD

Lead Sponsor: Imperial College London

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01960621

Discuss Mucinex

If you think you may have a medical emergency, call your doctor or 911 immediately.

By accessing this website, you are indicating your acknowledgement and acceptance of these Terms of Use. These Terms of Use are subject to change by WinFirst LLC at any time in its discretion. Your use of WinFirst LLC Site after such changes are implemented constitutes your acknowledgement and acceptance of the changes. Please consult these Terms of Use regularly.
PatientsVille.com does not provide medical advice, diagnosis or treatment. The information contained on PatientsVille.com site has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of adverse drug reactions or for establishing or changing of patient treatments.